Market Name: Sarafem

Generic Name: Fluoxetine HCl

Sarafem, an anti-depressant, has been shown to cause an increase in suicidal feelings and behavior in children and adolescents. While the FDA acknowledges that depression and other psychiatric disorders themselves are associated with increased risk of suicidal behavior, studies have shown that anti-depressants such as Sarafem have the potential to greatly increase this risk.

A black box warning detailing this risk was added to Sarafem's prescribing information by the FDA in February of 2005.

Black Box Warning Date: February 2005

FDA Link: Sarafem